Muvalaplin for Cardiovascular Disease

(MOVE-Lp(a) Trial)

Recruiting at 656 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Recent cardiovascular event, Heart surgery, Uncontrolled hypertension, Severe heart failure, Severe kidney impairment, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5.25 years

10450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests muvalaplin, a new treatment, to determine if it can lower the risk of heart problems such as heart attacks or strokes. The focus is on individuals with high levels of lipoprotein(a), a type of fat in the blood, who have experienced heart disease or are at risk for it. Participants will receive either muvalaplin or a placebo (a pill with no active medicine) to compare effects. Suitable candidates have high lipoprotein(a) and have had heart issues or are at risk due to factors like blocked arteries or diabetes. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that muvalaplin is likely to be safe for humans?

Research has shown that muvalaplin is well tolerated in people. In a previous 14-day study, muvalaplin reduced lipoprotein(a) levels by up to 65% without causing any major side effects. This suggests it is generally safe to use. However, further research is needed to confirm these results over a longer period and with more participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cardiovascular disease?

Muvalaplin is unique because it offers a new approach to treating cardiovascular disease. Unlike standard treatments, which often focus on managing symptoms or risk factors like cholesterol and blood pressure, Muvalaplin targets a specific pathway involved in the disease's progression. Researchers are excited about its potential to directly impact the underlying causes of cardiovascular problems, which could lead to more effective and lasting results. Additionally, Muvalaplin is taken orally, making it a convenient option for patients compared to some existing treatments that may require injections or more complex regimens.

What evidence suggests that muvalaplin might be an effective treatment for cardiovascular disease?

Research has shown that muvalaplin can significantly lower lipoprotein(a) levels, which are linked to heart disease. One study found that muvalaplin reduced these levels by up to 65%, offering promise for those at risk of heart attacks or strokes. Another trial confirmed that muvalaplin safely and effectively lowers high lipoprotein(a) without causing major side effects. These findings suggest muvalaplin could effectively reduce heart disease risk in individuals with high lipoprotein(a). Participants in this trial will receive either muvalaplin or a placebo to further evaluate its effectiveness and safety. ^{2 3 4 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Adults with high lipoprotein(a) levels (≥175 nmol/L) who have had a cardiovascular event in the last 10 years or are at risk of one due to conditions like coronary artery disease, carotid stenosis, peripheral artery disease, a high calcium score in their arteries, diabetes with reduced kidney function, or multiple high-risk factors. Excludes those with severe heart failure or kidney impairment, recent cancer or major cardiovascular events/surgery.

Inclusion Criteria

Have Lp(a) ≥175 nanomoles per liter (nmol/L)

Meet one of the following criteria:

I had a heart or blood vessel event due to plaque buildup in the last 10 years.

Exclusion Criteria

I have severe heart failure.

I have severe kidney problems.

I was diagnosed with cancer within the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either muvalaplin or placebo orally to evaluate the reduction of cardiovascular risk

5.25 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Muvalaplin

Trial Overview The trial is testing Muvalaplin's effectiveness against a placebo in reducing the risk of major cardiovascular events such as heart attacks and strokes in individuals with elevated Lipoprotein(a). Participants will be randomly assigned to receive either Muvalaplin or a placebo.

How Is the Trial Designed?

Group I: Muvalaplin Experimental Treatment 1 Intervention

Participants will receive muvalaplin orally.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12106114/

Promising results with the daily oral small molecule ... In the recent post hoc analysis of the Odyssey Outcomes trial, the PCSK9 inhibitor alirocumab improved cardiovascular outcomes after an acute ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07157774

NCT07157774 | Assessing the Impact of Muvalaplin on ... Study Overview​​ The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who ...

3. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/muvalaplin-lipoprotein-cardiovascular-disease-patients

Muvalaplin Found to Significantly Lower Lipoprotein(a) ... Results of the Phase II KRAKEN trial (NCT05563246) show that muvalaplin (Eli Lilly) produced a significant reduction in lipoprotein(a) levels ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2808864

Muvalaplin, an Oral Small Molecule Inhibitor of Lipoprotein ... Muvalaplin, a selective small molecule inhibitor of Lp(a) formation, was not associated with tolerability concerns and lowered Lp(a) levels up to 65% following ...

5. newsroom.heart.org newsroom.heart.org/news/in-a-small-international-trial-novel-oral-medication-muvalaplin-lowered-lp-a

In a small international trial, novel oral medication ... A clinical trial testing muvalaplin, a novel oral medication, was able to safely and effectively lower high levels of lipoprotein (a), according to late- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39556768/

Oral Muvalaplin for Lowering of Lipoprotein(a) A 14-day phase 1 study demonstrated that muvalaplin was well tolerated and reduced lipoprotein(a) levels up to 65%.

7. pharmacytimes.com pharmacytimes.com/view/kraken-trial-highlights-muvalaplin-s-efficacy-safety-in-reducing-lipoprotein-a-

KRAKEN Trial Highlights Muvalaplin's Efficacy, Safety in ... Based on data from a prior 14-day phase 1 clinical trial, muvalaplin treatment was well tolerated and reduced levels of Lp(a) by up to 65%.